- A single endoscopic intervention, duodenal mucosal resurfacing (DMR), can safely improve glycemic control over 12 months in patients with type 2 diabetes (T2D).
Why this matters
- A minimally invasive alternative to bariatric surgery could benefit more people with T2D.
- DMR involves catheter-based circumferential mucosal lifting followed by hydrothermal ablation of duodenal mucosa.
- Multicenter, phase 2, open-label study of 46 patients with T2D (HbA1c, 7.5%-10.0%), and BMI 24-40 kg/m2 on stable oral glucose-lowering medication before and for ≤24 weeks post-DMR.
- Funding: Fractyl Laboratories.
- No unanticipated adverse device events reported.
- In first follow-up year, 54 adverse events (AEs) deemed possibly, probably, or definitely procedure-related were reported in 24 patients in whom DMR was initiated (24/46, 52%).
- In per-protocol population with completed DMR (n=36), HbA1c was reduced from baseline by 10 mmol/mol at 24 weeks (P<.001 preserved at months.>
- Fasting plasma glucose was reduced by 1.7 (P<.001 and mmol at weeks months post-dmr respectively.>
- Weight loss was −2.5 kg (P<.001 at weeks and kg months did not significantly with hba1c either time point .078 respectively>
- Open-label, uncontrolled.
- Small sample size.